Xibrom performs well at Phase III

Article

Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.

Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) has achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.

In two multicentre, randomized, double-masked trials, 282 patients undergoing cataract surgery were dosed with either Xibrom or placebo once daily for one day before and 14 days following surgery.

In addition to achieving its primary endpoint, Xibrom also met the secondary endpoint of the trial: eradication of ocular pain at one day postoperatively. These results were cumulative: one of the trial arms showed statistical significance in achievement of both primary and secondary endpoints, while the second arm did not achieve statistical significance in either. In this second arm, there was a higher percentage of discontinuation due to lack of efficacy, and a greater reported response to placebo. There were no significant ocular or systemic adverse events in either trial arm, and an overall trend of decrease in photophobia was witnessed.

ISTA now plans to perform a further Phase III trial, which the company expects to conclude next year.

Recent Videos
Dr Rick Lewis discusses the FLigHT procedure and ViaLase laser at the 2024 European Society of Cataract and Refractive Surgeons (ESCRS) meeting
Christiana Dinah speaks about her ASRS presentation, Real-World Treatment Outcomes With Anti-VEGF Therapy in Patients With Retinal Vein Occlusion in the UK
Chase Ludwig, MD, shared an overview of his presentation, which covered real-impact of vitrectomy surgery on the progression of AMD at the annual ASRS meeting in Stockholm, Sweden
Patrick C. Staropoli, MD, discusses clinical characterisation of Hexokinase 1 (HK1) mutations causing autosomal dominant pericentral retinitis pigmentosa
Richard B. Rosen, MD, discusses his ASRS presentation on illuminating subclinical sickle cell activities using dynamic OCT angiography
ASRS 2024: Socioeconomic barriers and visual outcomes in patients with rhegmatogenous retinal detachments, from Sally S. Ong, MD
Ashkan Abbey, MD, speaks about his presentation on the the CALM registry study, the 36-month outcomes of real world patients receiving fluocinolone acetonide 0.18 mg at the annual ASRS meeting in Stockholm, Sweden.
Nikoloz Labauri, MD, FVRS, speaks at the 2024 ASRS meeting about suspensory macular buckling as a novel technique for addressing myopic traction maculopathy
Jordana Fein, MD, MS, speaks with Modern Retina about the IOP outcomes with aflibercept 8 mg and 2 mg in patients with DME through week 48 of the phase 2/3 PHOTON trial at the annual ASRS meeting in Stockholm, Sweden.
© 2024 MJH Life Sciences

All rights reserved.